Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute on Aging (NIA)
July 5, 2023 - This RFA has been reissued as RFA-AG-24-048
The purpose of this funding opportunity announcement (FOA) is to support research that can lead to the development of evidence-based primary care screening tools and behavioral interventions to prevent abuse in at-risk older and vulnerable adults with mild cognitive impairment (MCI) and Alzheimer’s disease and Alzheimer's disease-related dementias (AD/ADRD) and their families. Specifically, this FOA invites R61/R33 applications proposing Stage I screening and behavioral intervention development and Stage III efficacy trials in primary care settings. Studies must directly address the priority research needs and gaps highlighted in the U.S. Preventive Services Task Force’s 2018 final recommendation statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening for the development and validation of the following:
September 20, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| October 20, 2021 | Not Applicable | Not Applicable | March 2022 | May 2022 | July 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Funding Opportunity Announcement.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this Funding Opportunity Announcement (FOA) is to support research that can lead to the development of evidence-based primary care screening tools and behavioral interventions to prevent abuse in at-risk older and vulnerable adults with mild cognitive impairment (MCI) and Alzheimer’s disease and Alzheimer's disease-related dementias (AD/ADRD) and their families. Specifically, this FOA invites R61/R33 applications proposing Stage I screening and behavioral intervention development, and Stage III efficacy trials in primary care settings. Studies must directly address the priority research needs and gaps highlighted in the U.S. Preventive Services Task Force’s 2018 final recommendation statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening for the development and validation of the following:
This FOA solicits Stage I and Stage III studies as defined in the NIH Stage Model for Behavioral Intervention Development.
Background
The overarching goal of this FOA is to support intervention research that can lead to the development of accurate screening tools for detecting abuse and neglect in older and vulnerable adults as well as low-cost behavioral interventions for primary prevention with the potential for widespread dissemination and implementation. Elder abuse (EA), including physical, sexual, emotional, or psychological abuse; neglect; abandonment; and financial or material exploitation of older adults, is recognized as a significant public health problem. While all people with disabilities are at increased risk of victimization, people with impaired cognitive function and AD/ADRD are particularly vulnerable to all forms of EA.
Although the risk factors for EA are well known, it frequently goes undetected in clinical practice. Clinical encounters tend to be brief, with minimal time for assessment, let alone intervention. Furthermore, older adults rarely disclose EA and may go to great lengths to conceal it. Patients may refrain from disclosing altogether when family members accompany them to medical appointments, as is often necessary. For patients with AD/ADRD, issues of capacity and competency often cast doubt on the validity of their claims, particularly as aggression and agitation are also common behavioral and psychological symptoms of dementia. Given that common physical and psychological symptoms of AD/ADRD and treatment can overlap with the sequelae of abuse, clinicians may miss red flags. Moreover, as EA can be charged as a felony-level offense or a high-end misdemeanor, raising the topic creates an ethical challenge for clinicians if alternative caregiving options are not available, and when no current options exist for interventions for prevention and treatment.
Primary care providers are often the first to screen and evaluate patients for neurocognitive disorders, including MCI and dementia. Screening patients for EA prior to or early in the course of cognitive decline would create an opportunity for providers to deliver a brief psychoeducational intervention and/or to direct patients and families to appropriate health and social services. However, despite the increased awareness of EA and of the risk that people with AD/ADRD face, clinicians currently lack evidence-based screening tools with high specificity and sensitivity to improve diagnostic accuracy and early detection of EA and EA perpetration. Primary care health professionals also lack strategies for prevention and early intervention for all types of abuse.
Scope
This FOA invites studies that directly address the research needs and gaps identified in the 2018 Screening for Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults US Preventive Services Task Force Final Recommendation Statement; namely, (1) all areas related to screening tests and interventions in primary care settings for elder abuse and abuse of vulnerable adults when there are no recognized signs and symptoms of abuse, and (2) high-quality randomized clinical trials (RCTs) on the effectiveness (benefits and harms) of early screening and interventions in the primary care setting to prevent such abuse. For behavioral intervention development, NIA is soliciting research that can specify the underlying principle(s) or mechanism(s) of action of the intervention. Informed by the Elder Abuse and Abuse of Vulnerable Adults Analytic Framework that guided the Evidence Report and Systematic Review, which formed the basis of the U.S. Preventative Task Force's (USPSTF) 2018 Final Recommendation Statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening, responsive applications are required to focus on at least one of the following two key questions: KQ1 and/or KQ4, and to incorporate one or more of the other key questions (KQ2, KQ3, and KQ5) in the study design:
All applications submitted to this FOA are required to apply the NIH Stage Model framework to describe where an intervention is in the developmental pipeline and to specify research activities within different stages of intervention development. This FOA is only inviting research that will develop (Stage I, creation, adaptation, and piloting of an intervention), validate (Stage I), and test (Stage III, highly-controlled, high-internal-validity, community-based) primary care-based screening tools and/or brief interventions that can be offered in primary care settings (see Terms and Definitions below).
NIA seeks to support research aligned with guidance from the Agency for Healthcare Research and Quality's Evidence-based Practice Centers Program and lessons learned from the recent evidence-based reviews (see Methods Guidance in EPC Evidence-Based Reports and Care Interventions for People Living With Dementia and Their Caregivers ). Therefore, applications are required to specify and describe: (1) research methods for reducing the risk of selection bias, attrition bias, detection bias, performance bias, and reporting bias and (2) the criteria and quantitative measures for assessing the balance of benefits and harms of interventions to patients and medical visit companions.
NIA is particularly interested in supporting research that can promote health equity and address health disparities. To these ends, NIA encourages the development of screening tools and interventions with and for people who have been underrepresented in MCI and AD/ADRD intervention research (e.g., racial and ethnic minorities, sexual and gender minority populations (as defined on the homepage of NIH’s Sexual & Gender Minority Research Office | DPCPSI), older adults with disabilities and/or low literacy, non-English speakers, and those from socially, culturally, economically, or educationally disadvantaged backgrounds).
Specific Areas of Research Interest
There are several existing and emerging screening tools which show great promise; however, either there is insufficient evidence to support their efficacy, or they have not yet been adapted for use in screening for abuse in older or vulnerable adults or for use in primary care. For example, screening and detection methods and technologies that are being used to screen for intimate partner violence, child abuse, or elder abuse in emergency departments or by medics could be adapted for use in older and vulnerable adults, without recognized signs and symptoms of abuse, in primary care settings.
Screening for EA early in the course of cognitive decline could offer opportunities for clinicians to identify and provide a brief psychoeducational intervention to patients and families at high risk for EA and to direct them to appropriate health and social services. For example, the Screening, Brief Intervention, Referral to Treatment (SBIRT) intervention has proven to be an effective public health approach for early intervention and treatment of substance abuse.
When family members or companions accompany patients to their primary care medical encounters, this also could provide an ideal opportunity for screening family members to enable early identification of risk factors for both perpetration and victimization.
Another promising approach for harm-reduction is goal attainment scaling , where patients and their medical visit companions create an individualized set of goal items that align with their specific needs, which could be integrated into the plan of care.
Home-visiting programs for lowering the risk of child abuse could be adapted for older vulnerable adults and incorporate standardized outcome measures.
It will also be critical to include individuals from diverse populations and settings and address the possible need for cultural adaptations of screening tools or interventions in early Stage studies.
Phased Award Activities and Specific Requirements
This FOA supports bi-phasic studies for up to five years in total. The application must propose a well-defined set of specific aims and milestones for both the planning (R61) and implementation phase (R33). For the purpose of this FOA, milestones are defined as scheduled, performance-based events that signify the successful completion of a significant stage in the project. Milestones must be specific, quantifiable, and scientifically justified, and with well-defined criteria for success or go/no-go decisions within the R61 phase and for transitioning from the R61 to the R33 phase of the award. Responsive applications must include specific project milestones to be achieved by the end of the R61 phase and on an annual basis for the R33 phase. Investigators and NIA will review and mutually agree upon final revised milestones that will be included in the Terms and Conditions of the grant, if awarded. Prospective applicants should note that funding of a R61 phase grant application does not guarantee support of the R33 implementation phase. The transition from the R61 to the R33 phase of the award will be administratively reviewed for successful completion of the go/no-go criteria that will be clearly specified in the R61 phase. Transition to the R33 phase of the project will occur only if an administrative review process determines that the R61 planning activities have been successful, the implementation phase of the project can proceed with confidence of success, and funds are available.
Requirements for each phase are described below.
The R61 Planning Phase
R61-Appropriate Intervention Development Activities:
R61-Appropriate Research Goals:
R61 Research Milestones: The applicant must include clear milestones for the R61 phase. The specific activities and milestones appropriate for the R61 phase will depend on the individual application and its stage of development. Examples include, but are not limited to:
The R33 Implementation Phase: Stage III Efficacy Trials
During the R33 phase, the PD(s)/PI(s) will test the effectiveness of the intervention in a primary care setting. General activities for this phase include:
Responsiveness Criteria
Responsive applications are required to include the following elements:
Non-responsive applications will be administratively withdrawn and not reviewed for this FOA.
Additional Considerations
The National Institute on Aging (NIA) supports a central resource to NIA staff and extramural investigators to facilitate/support the conduct and management of clinical research. This resource, the Clinical Research Operations Management System (CROMS), is a comprehensive data management system to support the business functions, management, and oversight responsibilities of NIA grants that support the conduct of clinical research with human subjects. It is the expectation by NIA that all successful applicants will interface, integrate, or adapt their information system(s) and processes to interact with existing and future components of the CROMS as necessary.
Terms and Definitions
For the purposes of this FOA, unless otherwise specified, definitions for the following terms were adopted from the USPSTF’s 2016 Final Research Plan: Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening.
Elder abuse: Relevant types of abuse include physical abuse, sexual abuse, emotional or psychological abuse, neglect, abandonment, and financial or material exploitation.
Vulnerable adult: A vulnerable adult is considered a person who is or may be mistreated and who, because of age, disability, or both, is unable to protect themself.
Screening: A preventive service focused on detection of an undiagnosed disease in asymptomatic populations.
Primary care: Using the definition adopted by the Institute of Medicine (US) Committee on the Future of Primary Care, primary care refers to the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community.
Primary care setting: USPSTF recommendations address services offered or judged to be feasible in primary care settings or services referred by primary care professionals. The U.S. Preventive Services Procedure Manual (2015) states, To be feasible in primary care, the intervention should target patients seeking care in primary care settings, and the skills to deliver the intervention are or could be present in clinicians and/or related staff in the primary care setting, or the intervention could generally be ordered/initiated by a primary care clinician. Primary care settings include primary care clinics, emergency rooms, or other settings where primary care services are offered. This includes community-dwelling, assisted living settings where primary care services are delivered, and where patients/residents are able to live independently and receive care similar to a traditional primary care setting, and in nursing homes, for the purpose of this FOA.
Primary care providers: Primary care practitioners are defined as a Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Clinical Nurse Specialist (CNS), Nurse Practitioner (NP), or Physician Assistant (PA) who is certified in one of the following specialties: internal medicine, general medicine, geriatric medicine, family medicine, and/or hospice and palliative medicine.
NIH Stage Model framework: Applications under this FOA are required to use the NIH Stage Model framework. Information regarding the experimental medicine approach and the Science of Behavior Change (SOBC) can be found at https://commonfund.nih.gov/behaviorchange.
Frequently Asked Questions
Responses to Frequently Asked Questions about RFA-AG-22-024 will be posted here: https://www.nia.nih.gov/research/dbsr/behavioral-and-social-research-funding-opportunities-and-applicant-resources.
Applicants are strongly encouraged to consult with NIA staff when developing plans for an application (see Section VII, Agency Contacts). This early contact will provide an opportunity to clarify NIA policies and guidelines and identify whether the proposed project is consistent with NIA program priorities.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Required: Only accepting applications that propose clinical trial(s).
Need help determining whether you are doing a clinical trial?
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For the R61 phase, and pending annual appropriations, NIA intends to commit $5.6 million in FY 2022 and in FY 2023 to fund 5-7 R61 awards. For the R33 phase, and pending annual appropriations, NIA intends to commit $11.2 million in FY 2024, FY 2025, and FY 2026 to fund 5-7 R33 awards. |
Application budgets for the R61 and R33 phases must reflect the actual needs of the proposed project.
For the R61 phase, the combined budget for direct costs may not exceed $750,000, with no more than $500,000 requested in any single year.
For the R33 phase, if awarded, the combined budget for direct costs may not exceed $3,000,000.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
The maximum project period for the R61 planning phase is two years.
The maximum project period for the R33 phase is three years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Applications should include institutional Letters of Support from clinical settings where research will be conducted. Letters of Support should be attached to the PHS 398 Research Plan Form in the Other Research Plan Section, attachment #13.
All instructions in the SF424 (R&R) Application Guide must be followed.
The investigative team is required to include clinical expertise in primary care; clinical expertise in evaluating and/or caring for people with cognitive impairment and/or AD/ADRD and from the fields of elder mistreatment, child abuse and neglect, intimate partner violence, emergency medicine, and/or bioethics is strongly encouraged. Investigative teams are encouraged to cultivate a culture of inclusion and to be aligned with NIH's Interest in Diversity.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants are encouraged to budget for travel costs to attend and participate in one annual RFA grantee network meeting for each project year.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Describe specific aims for each of the two phases (R61 and R33) on the single Specific Aims attachment. Include headers indicating the R61 specific aims and the R33 specific aims.
Describe specific aims for research that can be conducted in primary care settings and that can address priority research needs and gaps highlighted in the U.S. Preventive Services Task Force’s 2018 final recommendation statement on Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: Screening, for: 1) screening tools and/or interventions for the abuse of older or vulnerable adults when there are no recognized signs or symptoms of abuse, and/or 2) assessing the balance of benefits and harms of screening and intervention in the primary care setting to prevent such abuse.
Describe specific aims that can address at least one of the two following key questions: KQ1 and/or KQ4, as appropriate, and that incorporate at least one of the other key questions (KQ2, KQ3, and/or KQ5) from the Elder Abuse and Abuse of Vulnerable Adults Analytic Framework in the proposed study design:
Research Strategy: The Research Strategy must contain separate sections that describe the R61 and R33 phases.
Milestones: The Research Strategy must contain separate sections that describe the R61 and R33 phases, as well as a sub-section that is devoted to describing milestones to be achieved during the R61 phase, to qualify for the transition to the R33 phase, and for the R33 phase.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
The NIH announced a policy on allowable appendix materials (NOT-OD-17-098); however this FOA allows specific materials to be included as appendices that are otherwise disallowed by the general policy. Applications may include as appendices the following materials: focus group guides, structured interview schedules, blank questionnaires or surveys with instructions, observational coding systems, fidelity monitoring checklists and rating tools, and draft or sample intervention manuals.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Section 3 - Protection and Monitoring Plans
3.3 Data and Safety Monitoring Plan
The Data and Safety Monitoring Plan (DSMP) should include a description of data monitoring activities, consistent with the NIA Guidance on Clinical Trials. This DSMP should include the following:
Do not name members of any oversight board in the application. The NIA will appoint members of any oversight committees after consultation with the clinical trial investigator team.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIA Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA:
Evaluate the appropriateness and adequacy of the proposed strategies for the assessment of: (1) the balance of benefits and harms of the proposed intervention(s) to patients and medical visit companions, if appropriate; and (2) the concordance of individual-level variables between the patient and provider on clinical decisions to screen or treat or patient decisions to consent to screening or treatment; and of the proposed plans.
Evaluate the appropriateness and rationale for: (1) the proposed Stage of Intervention Research (e.g., Stage I or III of the NIH Stage Model); (2) the hypothesized relevance of process variables (i.e., hypothesized causal targets) and outcome variables (i.e., ultimate behavior to be modified) to the clinical and statistical hypothesis being tested (i.e., the hypothesized role that each variable plays in the causal chain; specification of variables as hypothesized moderators, mediators, or outcomes); and (3) the intervention study design (e.g., single case study, multiple baseline design; adaptive/SMART design; factorial; partial factorial; etc.).?
Evaluate the adequacy of the proposed strategy for ensuring and assessing: (1) the fidelity of the intervention delivery; and (2) the reduction of the risk of bias for each of the following domains: (a) selection bias; (b) attrition bias; (c) detection bias; (d) performance bias; and (e) reporting bias.
Evaluate the appropriateness and adequacy of the proposed strategies for: (1) the assessment of decisional capacity and competency in the context of informed consent for patients with MCI or AD/ADRD; (2) the adherence of basic ethical principles of nonmaleficence, autonomy, beneficence, and justice, in the context of the study proposed, for both patients and medical visit companions; and (3) for reporting suspected and confirmed abuse according to laws, local regulations, and statutory mandates, both federal and state.
Evaluate the adequacy of the rationale provided for how the proposed strategies for the recruitment and retention of participants from underrepresented populations will promote health equity and address health disparities.
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Milestones: Evaluate whether the R61 milestones are adequately specified, developed, feasible, and quantifiable, with regard to the specific aims of each phase, and the adequacy of the success or go/no-go criteria with respect to outcomes, for advancing from the R61 to the R33 phase, and for the R33 phase. Specifically, are clear metrics of success defined for the investigators and NIA Program Officials to determine whether the project succeeded in (a) demonstrating initial proof of concept in the R61 phase, and (b) providing preliminary evidence that the new or refined screening tool and/or behavioral intervention can be implemented in primary care settings?
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Melissa S. Gerald, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3136
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7700
Email: [email protected]
John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.